AURAFLEX(R) ESTRADIOL— 510(k) K946199

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K946199 for AURAFLEX(R) ESTRADIOL, Substantially Equivalent on 1995-04-03. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code CHP
Advisory panel: Clinical Chemistry
Date received: 1994-12-20
Decision date: 1995-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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